CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
PATENT RIGHTS PURCHASE AGREEMENT
This Patent Rights Purchase Agreement (this "Agreement") is made and
entered into as of December 18, 1998 (the "Effective Date") between Isis
Pharmaceuticals, Inc. ("Isis"), and Gilead Sciences, Inc. ("Gilead").
1. DEFINITIONS.
1.1 "Cationic Lipid" means those compounds described in United
States Patent Nos. 5,777,153 and 5,705,693; United States Patent Application
Serial No. 08/672,206; and European Patent Application No. 97931462.2, to the
extent such compounds are not Codeblocker Compounds.
1.2 "Codeblocker Compound" means an oligonucleotide that binds
directly to DNA or RNA within a cell on a selective basis determined by the
nucleotide sequence of the target DNA or RNA and exerts its biological activity
predominantly through binding to DNA or RNA to inhibit the transcription or
replication of the target DNA or RNA or binding to RNA to inhibit the
translation, processing, packaging or regulatory activity of the target RNA. A
Codeblocker Compound may also have a mechanism of action or biological activity
other than one conferred through direct binding to RNA or DNA provided that (i)
the compound originally was designed to bind a target DNA or RNA and (ii) the
final compound or any compounds used to derive the final compound were not
identified using selective purification and polymerase amplification in any
fashion. An oligonucleotide, is any oligomer or polymer made up [***] An
oligonucleotide includes RNA or DNA fragments, and may be composed of naturally
occurring or non-naturally occurring bases, sugars or intersugar linkages. An
oligonucleotide may have the bases, sugars or intersugar linkages partially or
completely absent. Oligonucleotides may be made such that adjacent nucleoside or
nucleoside fragments are linked together by phosphate groups or modified or
non-naturally occurring internucleoside linkages to form the internucleoside
backbone of the oligomer, whether or not such linkages retain a phosphorous atom
in the linkage.
1.3 "Oligonucleotide Delivery System" means any carrier,
targeting entity, excipient, formulation, device, prodrug, covalent or
noncovalent conjugate, encapsulating vesicle, microcapsule, micro- or
nanosphere, emulsion, or microemulsion, lipid, liposome, virosome, or artificial
vial envelope which was developed by Gilead on or prior to the Effective Date,
and which (i) enhances the cellular penetration or circulating half-life of a
Codeblocker Compound, (ii) selectively delivers a Codeblocker compound to the
intended target tissue, cell or subcellular compartment, (iii) provides
sustained release of a Codeblocker Compound from a depot formulation, or (iv)
otherwise favorably alters the absorption, distribution, metabolism or excretion
of a Codeblocker Compound so as to enhance its pharmacological activity of
clinical value. "Oligonucleotide Delivery System" includes cationic lipids.
----------------------
[***] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
1.
1.4 "Patent Rights" means the patents and patent applications
listed in Exhibit A attached hereto.
2. ASSIGNMENTS AND LICENSES.
2.1 Gilead hereby sells and assigns to Isis all of Gilead's
right, title and interest in Patent Rights, subject to the rights of Glaxo
Wellcome Inc. ("Glaxo") under the Collaborative Research Agreement between Glaxo
and Gilead dated March 25, 1996 (the "Glaxo Agreement"), provided however, that
the assignment of U.S. Patent Number 5,256,775 shall be subject to the condition
precedent that Gilead settle the interference involving this patent on
conditions of Gilead's choosing (including conceding priority). Gilead hereby
grants Isis an exclusive, royalty-free, worldwide, assignable license (with the
right to grant sublicenses) to U.S. Patent Number 5,256,775 beginning on the
Effective Date and continuing until such time that Gilead settles the
interference and the assignment to Isis becomes effective.
2.2 Gilead hereby assigns and delegates to Isis (and Isis
accepts and agrees to perform) all of Gilead's rights and obligations under the
License Agreement between Xxxx Research Corporation ("Xxxx Research") and Gilead
dated January 1, 1994 and amended on November 19, 1996. A copy of the written
consent to such assignment and delegation signed by Xxxx Research is attached
hereto as Exhibit B. In the event that Isis, by reason of this Agreement, is
required to indemnify Xxxx Research under Section 8.1 (b) of the Xxxx Research
License Agreement, Gilead will indemnify Isis up to a maximum amount equal to
one hundred percent (100%) of total royalties received by Gilead from Xxxx
Research; thereafter, Gilead will not have any indemnity obligations to Isis
related to such Agreement. Gilead will continue to honor its obligations to Xxxx
Research for activities preceding the Effective Date of this Agreement.
2.3 Subject to the rights of Xxxx Research above, Isis hereby
grants to Gilead an exclusive, perpetual, irrevocable, royalty-free, worldwide,
assignable license (with the right to grant sublicenses) to directly or
indirectly make, have made, use, import, export or sell compounds and other
subject matter falling within the scope of Patent Rights which are [***]
2.4 Gilead hereby grants to Isis a nonexclusive, perpetual,
royalty-free, worldwide, assignable license (with the right to grant
sublicenses) to compounds and other subject matter which are within the scope of
Patent Rights, solely for use as intermediates in the manufacture of Codeblocker
Compounds or oligomers [***]
2.5 Isis hereby grants to Gilead a non-exclusive,
non-sublicensable, non-assignable, perpetual, irrevocable, royalty-free,
worldwide license under Patent Rights to make and use Codeblocker Compounds and
Oligonucleotide Delivery Systems for internal research purposes, but not for any
commercial purpose.
2.6 Isis will not have any obligations to Gilead relating to
Codeblocker Compounds or this Agreement to the extent arising prior to the
Effective Date.
----------------------
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SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
2.
2.7 Each party hereby agrees to execute such documents and to
take such other actions as shall be necessary or appropriate to effectuate the
assignments and licenses set forth in this Section 2.
3. REPRESENTATIONS AND WARRANTIES BY GILEAD.
Gilead makes the following representations and warranties to Isis, each of which
will survive the Effective Date:
3.1 To the best of Gilead's knowledge, the Patent Rights
include all of the patents and patent applications owned or controlled by Gilead
on or prior to the Effective Date that cover Codeblocker Compounds and
Oligonucleotide Delivery Systems, their manufacture or use. There are no other
US or unpublished foreign filings owned or controlled by Gilead filed prior to
the Effective Date which claim Codeblocker Compounds or Oligonucleotide Delivery
Systems other than as set forth in Exhibit A, nor does Gilead have any present
intention to make such filings. If Gilead becomes aware of any patents or patent
applications that (i) are owned or controlled by Gilead, (ii) claim inventions
made prior to the Effective Date, (iii) cover Codeblocker Compounds or
Oligonucleotide Delivery Systems, and (iv) are not included in Exhibit A, Gilead
will promptly notify Isis in writing and execute appropriate documents to
transfer such patents and patent applications to Isis.
3.2 Gilead represents and Isis acknowledges that (i) the Glaxo
Agreement remains in effect and Gilead and Glaxo have ongoing rights and
obligations thereunder, modified to the extent specifically set forth in this
Agreement and (ii) this Agreement is not an assignment of Gilead's rights or
obligations under the Glaxo Agreement and that Isis assumes no rights or
obligations to Glaxo under this Agreement. Gilead represents that the Research
Term and all rights, obligations and funding relating thereto under the Glaxo
Agreement have been terminated. Gilead will not enter into any future amendments
to the Glaxo Agreement which in any way affect the rights of Isis hereunder.
3.3 The Glaxo Agreement and the license to Xxxx Research
referenced in Section 2.2 above are the only licenses and Gilead is not aware of
any other third party rights of any kind affecting the Patent Rights. Except
with respect to U.S. Patent Number 5,256,775, which is subject to an
interference proceeding, the Patent Rights are not the subject of any pending
interference, cancellation or other protest proceeding not otherwise known to
Isis, or otherwise subject to rights or obligations to any third party other
than Glaxo and Xxxx Research. The complete terms and conditions of such rights
and obligations relating to Glaxo and Xxxx Research have been disclosed to Isis.
3.4 There are no Collaboration Compounds (as defined in Section
1.7 of the Glaxo Agreement) and none were developed during the Research Term
under the Glaxo Agreement. Gilead does not owe any royalties to Glaxo or any
third party under the Glaxo Agreement nor does Gilead have any known or pending
claims against Glaxo arising out of the Glaxo Agreement. To the best of Gilead's
knowledge, (i) Glaxo does not owe any royalties to Gilead or any third party
under the Glaxo Agreement, (ii) nor does Glaxo have any known or pending claims
against Gilead arising out of the Glaxo Agreement.
3.
4. TECHNOLOGY TRANSFER.
4.1 Gilead and Isis will cooperate in the filing and execution
of any and all documents necessary to effectuate the assignment to Isis of the
Patent Rights, including the filing of assignments or other transfer of title
covenants with the U.S. Patent and Trademark Office and foreign patent offices
as applicable to the Patent Rights. Within thirty (30) days from the Effective
Date, Gilead will notify all attorneys handling the prosecution of the Patent
Rights to contact the Isis Patent Department to provide an immediate status
update on the Patent Rights and to prepare the documents necessary to transfer
the Patent Rights to Isis. The cost of recording assignments of the Patent
Rights will be borne by Isis. Within forty-five (45) days from the Effective
Date, Gilead and its counsel will use their reasonable best efforts to transfer
all files and supporting documents relating to the Patent Rights to Isis,
including but not limited to, all initial invention disclosure documents, all
documents sent to the U.S. Patent and Trademark Office regarding inventions and
claims, all draft patent applications, all filing or prosecution documents
submitted to the patent offices, and all file wrappers. Conception notebooks and
all other documents in the possession or under the control of Gilead or its
counsel relating to conception and/or reduction to practice, such as scientist
notebooks shall be obtained in accord with Gilead's ordinary document retention
and made available to Isis upon Isis' reasonable request. All documents to be
provided to Isis hereunder are to be sent by expedited delivery service.
4.2 Gilead will make appropriate scientific staff available to
Isis for a scientific tutorial on the subject matter of this Agreement, such
tutorial not to exceed more than [***] from Gilead's staff and not to obligate
Gilead to disclose any third party confidential information.
5. PATENT MAINTENANCE AND PROSECUTION RESPONSIBILITIES.
5.1 On and after the Effective Date, Isis will take
responsibility for any action or proceeding involving Patent Rights. The cost of
recording the assignment of Patent Rights shall be borne solely by Isis. If Isis
elects not to take such responsibility involving Patent Right(s) in a particular
country then Isis will timely notify Gilead and Glaxo 30 days before the time
future action is due, and thereafter Gilead or Glaxo shall undertake such
responsibility. If Gilead or Glaxo elects to do so, Isis will grant any
necessary authority to Gilead. Gilead will determine whether Gilead or Glaxo
shall take such responsibility at their expense. Isis assumes no obligation to
Glaxo as a result of its agreement with Gilead in this Section 5.1.
5.2 NOTICE OF INFRINGEMENT. Isis shall promptly notify Gilead
in writing of any infringement of any assigned Patent Right(s) of which it
becomes aware.
5.3 ENFORCEMENT OF PATENTS. Except as otherwise set forth in
this Section, Isis may, but shall not be required to, prosecute any alleged
infringement or threatened infringement of any assigned Patent Right(s) of which
it is aware or which is brought to its attention. Isis shall act in its own name
and at its own expense. If Isis has failed to prosecute under the first sentence
of this paragraph with respect to alleged or threatened infringement
----------------------
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RESPECT TO THE OMITTED PORTIONS.
4.
relating to any Patent Right(s) (i) two months after it has been notified in
writing of such alleged infringement, or (ii) one month before the time limit,
if any, set forth in the appropriate laws and regulations for the filing of such
actions, whichever comes first, Gilead (or at its election Glaxo) may, but shall
not be required to, prosecute any such alleged infringement or threatened
infringement of a Patent within the Patent Rights. In any such event, Gilead or
Glaxo shall be free to act in its own name and at its own expense.
Notwithstanding the foregoing and as between the parties, Gilead shall have the
sole and exclusive right of enforcement with respect to any alleged or
threatened infringement of any right within the scope of the license granted in
Section 2.3 of this Agreement. Isis shall cooperate fully with Gilead or Glaxo
in any action by Gilead or Glaxo, respectively, under this paragraph, including
if required in order to bring such an action, the furnishing of a power of
attorney.
6. INDEMNITY AND WARRANTY.
6.1 Indemnity by Isis. Isis will indemnify, save, defend and
hold Gilead and its agents, directors and employees harmless from and against
any and all suits, claims, actions, demands, liabilities, expenses and/or loss,
including reasonable legal expense and attorneys fees, resulting from activities
under this agreement by Isis.
6.2 INDEMNITY BY GILEAD. Gilead will indemnify, save, defend
and hold Isis and its agents, directors and employees harmless from and against
any and all suits, claims, actions, demands, liabilities, expenses and/or loss,
including reasonable legal expense and attorney fees, resulting from (i)
Gilead's, Gilead's sublicensee's or Gilead's assignee's activities under the
licenses provided for in Sections 2.3 and 2.5; (ii) Gilead's contractual
obligations to third parties including Glaxo and Xxxx Research, except to the
extent resulting from Isis' activities under this Agreement; or (iii) Gilead's
exercise of the Patent Rights prior to the Effective Date.
6.3 WARRANTY. Gilead warrants that it has sufficient right and
title to enter into and to perform its obligations under this Agreement. EXCEPT
AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE PARTIES DISCLAIM ALL WARRANTIES OF
ANY NATURE, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF
VALIDITY, MERCHANTABILITY, NONINFRINGEMENT, AND FITNESS FOR A PARTICULAR
PURPOSE.
7. CONFIDENTIALITY. Confidential Information under the terms
of this Agreement is all information relating to the Patent Rights sold,
assigned or licensed to Isis under Section 2.1 and the Technology Transfer to
Isis by Gilead under Section 4.1. Gilead agrees to treat the Confidential
Information as confidential and to protect and maintain the confidentiality
thereof. Gilead will use at least the same standard of care as it uses to
protect its own Confidential Information to ensure that its employees, agents,
and consultants do not disclose or make any unauthorized use of such
Confidential Information. Gilead will promptly notify Isis upon discovery of any
unauthorized use or disclosure of the Confidential Information. Confidential
Information will not include any information which is generally available to the
public, is otherwise part of the public domain other than through any act or
omission of Gilead in breach of this Agreement, or which is required to be
disclosed by law or contract entered into
5.
prior to this Agreement (provided that Isis shall have notice thereof in advance
so that it can act to protect its interests should it decide to do so).
8. CONSIDERATION. Isis shall pay Gilead the following
noncontingent, non-refundable cash payments as consideration for the assignments
provided for in this Agreement: $2,000,000 on the Effective Date, $1,000,000 on
the first anniversary of the Effective Date, $1,000,000 on the second
anniversary of the Effective Date, and $2,000,000 on the third anniversary of
the Effective Date, for total payments of $6,000,000. In the event that Isis
defaults on any of these payments, after thirty (30) days notice and an
opportunity to cure, then ownership of all Patent Rights will automatically
revert to Gilead and Isis will take all actions reasonably requested by Gilead
for such purposes, including, without limitation, signing and delivering any
applicable assignments and other documents. Isis shall be entitled to no damages
exceeding the consideration set forth in this Section 8 for any uncured claim
against Gilead respecting Gilead's performance or representations hereunder.
9. NOTICES. Notices under this Agreement shall be sufficient
only if personally delivered, delivered by a major commercial rapid delivery
courier service, facsimile or mailed by certified or registered mail, return
receipt requested, to a party at its addresses set forth as follows:
If to Isis: Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
Attn: Executive Vice President, CFO
Facsimile: (000) 000-0000
If to Gilead: Gilead Sciences, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxx Xxxx, XX 00000
Attn: Vice President, Intellectual Property
Facsimile: (000) 000-0000
If to Glaxo: Glaxo Wellcome, Inc.
Five Xxxxx Xxxxx
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000
Attn: Company Secretary
Facsimile: (000) 000-0000
10. MISCELLANEOUS. If any provision of this Agreement shall be
adjudged by any court of competent jurisdiction to be unenforceable or invalid,
that provision shall be limited or eliminated to the minimum extent necessary to
continue to effect the intent of the parties, and this Agreement shall otherwise
remain in full force and effect and enforceable. Any waivers or amendments shall
be effective only if made in writing and signed by a representative of the
respective parties authorized to bind the parties. This Agreement shall be
governed by the laws of the State of Delaware, excluding conflicts-of-law
principles. This Agreement is the complete and exclusive statement of the mutual
understanding of the parties and supersedes and cancels all previous written and
oral agreements and communications relating to the subject matter of this
6.
Agreement, excluding the Confidential Disclosure Agreement between the parties
dated July 29, 1998.
7.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
day and year first indicated above.
ISIS PHARMACEUTICALS, INC. GILEAD SCIENCES, INC.
By: By:
------------------------------- ----------------------------------
Printed: Printed:
-------------------------- -----------------------------
Title: Title:
---------------------------- -------------------------------
Address: 0000 Xxxxxxx Xxxxxx Address: 000 Xxxxxxxx Xxxxx
Xxxxxxxx, XX 00000 Xxxxxx Xxxx, XX 00000
8.
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EXHIBIT B
December 16, 1998
VIA FACSIMILE AND COURIER
Xxxx Xxxxxx, Ph.D.
Xxxx Research Corporation
00000 Xxxxx Xxxxx
Xxxxxxxx, XX 00000
RE: ASSIGNMENT OF LICENSE AGREEMENT
Dear Xxxx:
As we discussed today by phone, Gilead has negotiated a Patent Rights Purchase
Agreement with Isis Pharmaceuticals, Inc. ("Isis"), a biopharmaceutical company
based in Carlsbad, California, pursuant to which Gilead will assign all of its
antisense patent rights to Isis. As part of this Agreement, Gilead will be
assigning to Isis the License Agreement between Gilead and Xxxx Research
Corporation dated January 1, 1994, as amended November 19, 1996 (the "License
Agreement"). The purpose of this letter is to obtain the formal consent of Xxxx
Research Corporation to the proposed assignment of the License Agreement to
Isis, as required by Section 16 of the License Agreement. Please indicate your
consent to the assignment by executing and dating this letter in the space
indicated below and returning it to my attention via facsimile at (650)
577-5488. When you receive the original copy of the letter please execute and
date it (using the same date) and return it to me by courier.
We would be happy to discuss the proposed assignment in more detail with you, or
put you in touch with appropriate people at Isis. Please give me a call at (650)
000-0000, or Xxxx Xxxxxxxx at (000) 000-0000, if you have any questions. Thank
you for your prompt response to this matter.
Very truly yours,
Xxxxxxx X. Xxxx, M.D., Ph.D.
Senior Vice President, Business Operations
ACCEPTED AND AGREED TO:
Xxxx Research Corporation
By
------------------------------
Name:
Title:
Date:
